A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies
- Thrombocytopenia, Neonatal Alloimmune
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 39
- Started
- 11 November 2024
- Main results due
- 5 December 2029
- Study sites
- 21
- Registry updated
- 25 September 2026
Can you take part?
- Ages 18 years to 45 years.
- Women only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Pregnant and an estimated gestational age (GA; based on ultrasound dating) from Week 13 to 18 at randomization * Has a history of greater than or equal to (\>=) 1 prior pregnancy with fetal and neonatal alloimmune thrombocytopenia (FNAIT) (including neonatal platelet count less than (\<) 150×10\^9/Liter) with none of them affected by fetal/neonatal intracranial hemorrhage (ICH) or severe hemorrhage based on a clinical review of the medical records * Current pregnancy with presence of maternal anti- human platelet antigen (HPA)-1a alloantibody and positive fetal HPA-1a genotype as confirmed by cell-free fetal deoxyribonucleic acid (DNA) in maternal blood * Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead Electrocardiogram (ECG), and clinical laboratory tests performed at screening * For maternal participant and neonate/infant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit Exclusion Criteria: * Currently pregnant with multiple gestations (twins or more) * History of severe preeclampsia in a previous pregnancy * History of myocardial infarction, unstable ischemic heart disease, or stroke * Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients (refer to the Investigator Brochure (IB)) * Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
What this study is about
In the sponsor’s own words, from the registry.
The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).
Study sites(21)
Universitair Ziekenhuis Leuven
Leuven, Belgium
Recruiting
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Brazil
Completed
IDOR - Regional Rio de Janeiro
Rio de Janeiro, Brazil
Completed
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, Brazil
Completed
CHRU Lille
Lille, France
Recruiting
Hopital trousseau- APHP
Paris, France
Recruiting
Semmelweis Egyetem
Budapest, Hungary
Recruiting
Sheba Medical Center
Ramat Gan, Israel
Completed
Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico
Milan, Italy
Recruiting
Fondazione Policlinico Universitario A Gemelli IRCCS
Rome, Italy
Recruiting
Haukeland University Hospital
Bergen, Norway
Recruiting
Oslo University Hospital HF Ulleval sykehus
Oslo, Norway
Recruiting
Universitetssykehuset Nord-Norge HF
Tromsø, Norway
Recruiting
St. Olavs Hospital
Trondheim, Norway
Recruiting
Univerzitna nemocnica L. Pasteura Kosice
Košice, Slovakia
Recruiting
Univerzitná nemocnica Martin
Martin, Slovakia
Recruiting
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, Slovakia
Recruiting
Univerzitetni klinicni center Ljubljana
Ljubljana, Slovenia
Recruiting
Hosp. Virgen Del Rocio
Seville, Spain
Completed
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden
Recruiting
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, Switzerland
Recruiting
Showing 21 of 21 sites. 16 of the 21 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06449651. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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